Duns Number:022721133
Device Description: Mac 1/Medium SINGLE USE DISPSOABLE LARYNGOSCOPE SYSTEM. One disposable handle and one disp Mac 1/Medium SINGLE USE DISPSOABLE LARYNGOSCOPE SYSTEM. One disposable handle and one disposable blade.
Catalog Number
1021.C.2015.C
Brand Name
IntuBrite
Version/Model Number
1021.C.2015.C
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCW
Product Code Name
Laryngoscope, Rigid
Public Device Record Key
014931ce-eef1-4220-8ab0-5c6cda632105
Public Version Date
March 26, 2019
Public Version Number
1
DI Record Publish Date
March 18, 2019
Package DI Number
10607411969673
Quantity per Package
10
Contains DI Package
00607411969676
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |